| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K153174 |
04/13/2016 |
Ketac Universal Aplicap |
3M DEUTSCHLAND GMBH |
RUEDIGER FRANKE |
| K152086 |
04/28/2016 |
3Shape Ortho System |
3Shape A/S |
Hanne Nielsen |
| K151953 |
04/13/2016 |
A&D Medical TM-2657 Family of Digital Blood Pressure Monitors |
A&D COMPANY, LTD |
JERRY WANG |
| K153093 |
04/07/2016 |
FIRMap Catheter |
ABBOTT ELECTROPHYSIOLOGY |
DENNIS POZZO |
| K160236 |
04/27/2016 |
Dual Pump Pack |
Abbott Medical Optics Inc. |
Priya Viswanathan |
| K160390 |
04/11/2016 |
Map-it Diagnostic Mapping Catheters |
ACCESS POINT TECHNOLOGIES EP, INC. |
SEAN CARROLL |
| DEN150028 |
04/07/2016 |
PneumoLiner |
ADVANCED SURGICAL CONCEPTS LTD. |
EDWARD HYLAND |
| K152724 |
04/27/2016 |
EYEPRINTPRO (ROFLUFOCON D) SCLERAL GP LENSES |
ADVANCED VISION TECHNOLOGIES |
KEITH PARKER |
| K152365 |
04/21/2016 |
AgaMatrix Jazz Wireless 2 Blood Glucose Monitoring System |
AgaMatrix, Inc. |
David Olsen |
| K153603 |
04/29/2016 |
Alphatec Navigation Instruments |
ALPHATEC SPINE, INC. |
RENEE MURPHY |
| K153152 |
04/27/2016 |
Syzygy Stabilization System |
AMENDIA, INC. |
Kristen Allen |
| K160432 |
04/22/2016 |
Anzai Respiratory Gating System |
ANZAI MEDICAL CO, LTD. |
NAOYA IWASAKI |
| K160461 |
04/12/2016 |
Arthrex iBalance BiCompartmental Arthroplasty System |
Arthrex, Inc. |
Courtney Smith |
| K151527 |
04/19/2016 |
Arthrex Univers Revers CA Heads and Adapters |
ARTHREX, INC. |
COURTNEY SMITH |
| K152454 |
04/11/2016 |
HemiCAP MTP Resurfacing Hemi-Arthroplasty System |
ARTHROSURFACE, INC. |
DAWN J. WILSON |
| K160659 |
04/07/2016 |
ASAHI CHIKAI Neurovascular Guide Wire (Round Curve) |
ASAHI INTECC CO., LTD. |
CARROLL COUNCILMAN |
| K153446 |
04/08/2016 |
OLYMPIC Posterior Spinal Fixation System |
Astura Medical |
Troy Taylor |
| K151357 |
04/22/2016 |
MIRI TL |
AT MEDICAL UAB |
THOMAS PEDERSEN |
| K160827 |
04/21/2016 |
Pantheris Catheter |
AVINGER, INC. |
Golnaz Moeini |
| K153293 |
04/06/2016 |
Extension Set |
B. BRAUN MEDICAL INC. |
Kimberly Smith |
| K153481 |
04/04/2016 |
0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe |
BECTON, DICKINSON AND COMPANY |
John Blewitt |
| K160651 |
04/07/2016 |
BD FlowSmart Set, MiniMed Pro-Set |
BECTON, DICKINSON AND COMPANY |
Matthew Trachtenberg |
| K152563 |
04/18/2016 |
Pulse Oximeter (MD300M/MD300K2) |
BEIJING CHOICE ELECTRONIC TECHNOLOGY CO., LTD. |
LEI CHEN |
| K160343 |
04/07/2016 |
SIGMA P5/ OMEGA P7/ LAMBDA P9 Portable Ultrasound Diagnostic Scanner |
BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD |
JUNE LI |
| K160112 |
04/29/2016 |
Besmed PEEP Valve |
BESMED HEALTH BUSINESS CORP. |
ERIC LI |
| K160459 |
04/01/2016 |
FilmArray Gastrointestinal Panel (GI) for use with FilmArray Torch |
BIOFIRE DIAGNOSTICS, LLC |
Kristen J. Kanack |
| K152075 |
04/15/2016 |
VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) |
bioMerieux, Inc |
Cherece L Jones |
| K153558 |
04/21/2016 |
Ventix Suture Anchor |
BIOMET MANUFACTURING CORP. |
Adam Cargill |
| K153229 |
04/12/2016 |
Superbium |
BIOS S.R.L |
Riccardo Pisati |
| K152995 |
04/11/2016 |
BioMonitor 2-AF, BioMonitor 2-S |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K160227 |
04/22/2016 |
ACCENTO / HWA Dual/Single laser |
BISON MEDICAL CO LTD |
SUN WOO LEE |
| K153064 |
04/29/2016 |
Blue Sky Bio Zygomatic Implant System |
BLUE SKY BIO, LLC |
Michele Vovolka |
| K153653 |
04/13/2016 |
DICOM Viewer |
Brainlab AG |
Rainer Birkenbach |
| K160866 |
04/29/2016 |
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit |
C.R. BARD, INC. |
LAURIE SANG |
| K152329 |
04/13/2016 |
Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System |
C2 Therapeutics, Inc. |
Theresa Brandner-Allen |
| K160285 |
04/25/2016 |
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202 |
CAPILLUS, LLC |
PATRICIA SCHNOOR |
| K153581 |
04/08/2016 |
Bladder Scanner |
Caresono Technology Co., Ltd. |
Yuzhong Ma |
| K153192 |
04/18/2016 |
Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen Dip Card/Cup with OPI 2000 Tests |
Chemtron Biotech, Inc. |
Jane Zhang |
| K151683 |
04/05/2016 |
SleepWeaver Advance Pediatric Nasal CPAP Mask |
Circadiance, LLC |
David Groll |
| K153050 |
04/26/2016 |
Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard |
Co-Innovation Biotech Co., Ltd |
Hong Feng |
| K152927 |
04/28/2016 |
BRILLIANT EVERGLOW |
COLTENE/WHALEDENT AG |
SILKE WALLASCHEK |
| K160858 |
04/26/2016 |
CompactCath Intermittent Urinary Catheter |
COMPACTCATH INC. |
Naama Stauber Breckler |
| K160869 |
04/29/2016 |
Biodesign Tissue Graft, Biodesign Dural Graft, Biodesign Peyronie's Repair Graft |
COOK BIOTECH INCORPORATED |
Perry W. Guinn |
| K160223 |
04/08/2016 |
VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter |
COOK INCORPORATED |
STEVEN LAWRIE |
| K152084 |
04/29/2016 |
Bencox M Stem (Bencox Hip System) and Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug |
CORENTEC CO., LTD |
J S Daniel |
| K152590 |
04/15/2016 |
ACCU NEWS Drug Screening Test Card/Urine Cup |
CORETESTS, INC |
ERIC SUN |
| K152903 |
04/29/2016 |
REVIVAL(TM) Modular Revision Hip Stem |
CORIN USA |
DIANA L. NADER-MARTONE |
| K160176 |
04/26/2016 |
Signia Stapler |
Covidien |
Frank Gianelli |
| K160360 |
04/05/2016 |
Barrx FLEX RFA Energy Generator |
Covidien llc |
Timothy Thomas |
| K152794 |
04/12/2016 |
Cytosponge Cell Collection Device |
Covidien LLC |
Clare Santulli |
| K160300 |
04/22/2016 |
MotoBand(TM) CP Implant System |
CrossRoads Extremity Systems, LLC |
Vernon Hartdegen |
| K160968 |
04/14/2016 |
iPulse SmoothSkin Gold Hair Removal Device |
CYDEN LIMITED |
MIKE KIERNAN |
| K153411 |
04/08/2016 |
430 Torque High-Speed Handpiece Series - 430 SWL Torque High Speed Handpiece, 430 SW Torque High Speed Handpiece |
DENTALEZ, INC. |
DAN LASKOWITZ |
| K153639 |
04/08/2016 |
OneQ-SL s-Clean Implant System |
DENTIS CO., LTD. |
SUN CHUL SHIN |
| K153696 |
04/14/2016 |
Chattanooga Revolution Wireless |
DJO, LLC |
NATALIA SHIRINA |
| K153634 |
04/06/2016 |
Wireless Earlens Light Driven Hearing Aid |
EARLENS CORPORATION |
Deborah Arthur |
| K160790 |
04/04/2016 |
Acclarix LX8 Diagnostic Ultrasound System |
Edan Instruments Inc |
Queena Chen |
| K152552 |
04/29/2016 |
Patient Monitor |
EDAN INSTRUMENTS, INC. |
QUEENA CHEN |
| K143690 |
04/01/2016 |
EksoÖ (version 1.1) and Ekso GTÖ (version 1.2) |
EKSO BIONICS, INC. |
JOHN TUGWELL |
| K160440 |
04/20/2016 |
Leksell Gamma Knife Icon |
Elekta Instrument AB |
Alf Laurell |
| K160325 |
04/04/2016 |
PRECICE Intramedullary Limb Lengthening System |
ELLIPSE TECHNOLOGIES, INC. |
Cora Sim |
| K160914 |
04/22/2016 |
sterEOS Workstation |
EOS IMAGING, INC. |
MATHIAS BREUIL |
| K151650 |
04/04/2016 |
SMARTez elastomeric infusion pump |
Epic Medical Pte Ltd |
Freddie Lee |
| K160128 |
04/28/2016 |
Endopath Electrosurgery Probe Plus II |
Ethicon Endo-Surgery, LLC |
Marjorie Medina |
| K152553 |
04/22/2016 |
CueSee Hypoxic |
EUROTROL B.V. |
Paul Kooijmans |
| K153305 |
04/08/2016 |
EyeYon (hioxirilcon D) Soft (hydrophillc) ContactLensesfor Daily Wear, Hyper-CL (hioxirilcon D)TherapeuticSoft (hydrophillc) Contact Lensesfor Daily Wear |
EYEYON MEDICAL |
MALCA CHEN-ZION |
| K153583 |
04/01/2016 |
BioVision Plus |
FAXITRON BIOPTICS LLC |
CARLOS REYES |
| K151156 |
04/01/2016 |
Fiagon Navigation System |
FIAGON GMBH |
DIRK MUCHA |
| K153638 |
04/19/2016 |
Bicortical Fixation Screw & Washer Nut System |
FIRST RAY LLC |
ROBERT HOY |
| K153622 |
04/08/2016 |
First Ray Internal Bone Staple System |
FIRST RAY LLC |
Robert Hoy |
| K160299 |
04/08/2016 |
geko(TM) Plus R-2 Neuromuscular Stimulator |
FIRSTKIND LIMITED |
NEIL BUCKLEY |
| K160195 |
04/15/2016 |
Forma System, Forma Light System |
FORMATK SYSTEMS LTD. |
AMIT GOREN |
| K153566 |
04/06/2016 |
Magma System |
FORMATK SYSTEMS LTD. |
AHAVA STEIN |
| K150914 |
04/21/2016 |
Dash-Topic Plus Cream |
Founders Science Group, LLC |
Ronald M Gurge |
| K153449 |
04/26/2016 |
2008K2 Hemodialysis Machine |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
DENISE OPPERMANN |
| K160749 |
04/15/2016 |
CRIT-LINE III Blood Chamber II |
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC |
Denise Oppermann |
| K153464 |
04/08/2016 |
FDR D-EVO flat Panel Detector System |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
Katherine Y. Choi |
| K160674 |
04/19/2016 |
Fujifilm Sonosite Vevo MD Imaging System |
FUJIFILM SONOSITE, INC. |
SCOTT PAULSON |
| K160734 |
04/05/2016 |
SonoSite SII Ultrasound System |
FUJIFILM SonoSite, Inc. |
Patricia Liau |
| K151502 |
04/28/2016 |
ARCHITECT ROMA |
Fujirebio Diagnostics, Inc. |
Diana Dickson |
| K153361 |
04/15/2016 |
Lumipulse G 25-OH Vitamin D, Lumipulse G 25-OH Vitamin D Calibrators |
FUJIREBIO DIAGNOSTICS, INC. |
STACEY DOLAN |
| K152652 |
04/05/2016 |
PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement |
GAIA DENTAL PRODUCTS, INC. |
WEITAO JIA |
| K151503 |
04/05/2016 |
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE |
GBUK Enteral Limited |
Mark Thompson |
| K160162 |
04/26/2016 |
Voluson P6, Voluson P8 |
GE HEALTHCARE |
Tracey Ortiz |
| K160633 |
04/22/2016 |
G3(TM) Active Plate(R) Small Fragment System |
GENESIS FRACTURE CARE, INC. |
Michael Bottlang |
| K153123 |
04/26/2016 |
Genesys Spine Apache Interbody Fusion System |
GENESYS SPINE |
Dave Lamb |
| K151731 |
04/15/2016 |
Rainbow Paste Stain |
GENOSS |
BYUNGSUN KIM |
| K151086 |
04/28/2016 |
ManoScan System |
GIVEN IMAGING LTD. |
HILLA DEBBY |
| K153590 |
04/22/2016 |
AvaDent Denture Base Material |
Global Dental Science |
Chuck Johnson |
| K152701 |
04/22/2016 |
Matrix Mini ECG Monitor |
GLOBAL INSTRUMENTATION, LLC |
CRAIG SELLERS |
| K143578 |
04/13/2016 |
SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K152222 |
04/21/2016 |
NITRILE BLUE POWDER FREE EXAMINATION GLOVES tested for use with Chemotheraphy Drugs |
GMP MEDICARE SDN BHD (F25) |
MS.EVA VINONI MUSTAFA |
| K153255 |
04/13/2016 |
Aero Chrome* Breathable Performance Surgical Gown |
Halyard Health, Inc. |
DAVID M. LEE |
| K152077 |
04/21/2016 |
MaxiGen |
HANS BIOMED CORP. |
LUCY CHOI |
| K152107 |
04/12/2016 |
HealthChek Network Health Station |
HEALTHCHEK NETWORK, LLC |
JAMES EVANS |
| K152479 |
04/04/2016 |
HG Pro Nitrile Powder Free Examination Gloves |
HEALTHY GLOVE CO.,LTD |
TEOH CHOH SHEE |
| K153737 |
04/22/2016 |
OSTEOPAL plus |
HERAEUS MEDICAL GMBH |
ASTRID MARX |
| K153614 |
04/21/2016 |
PROBEAT-V and accessories |
HITACHI, LTD., HEALTH CARE COMPANY |
NAOYA NISHIMURA |
| K153486 |
04/01/2016 |
Affirm Prone Biopsy System |
Hologic Inc |
Sarah Fairfield |
| K143612 |
04/08/2016 |
LifeCare PCA Infusion System |
Hospira, Inc |
Tom Gutierrez |
| K152228 |
04/04/2016 |
Hydroven 12, Hydroven 12 Garments |
HUNTLEIGH HEALTHCARE LTD |
GREG BAILY |
| K160160 |
04/05/2016 |
Non-Telescopic PenEvac |
I.C. Medical, Inc. |
Elena S. Buiga |
| K153694 |
04/19/2016 |
Icare ic100 |
Icare Finland Oy |
Matti Tulikoura |
| K160266 |
04/08/2016 |
ICONACY(TM) I-Hip(TM) |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
Thomas R. Allen |
| K151977 |
04/12/2016 |
icotec Pedicle System |
ICOTEC AG |
JORG SCHNEIDER |
| DEN140022 |
04/20/2016 |
GLAUCOMA COMPANION |
INNOVATEX, INC. |
STEPHEN C CHEN |
| K152013 |
04/11/2016 |
QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls |
INOVA DIAGNOSTICS, INC. |
Gabriella Lakos |
| K160252 |
04/27/2016 |
OmniPod Insulin Management System |
INSULET CORPORATION |
MATTHEW KING |
| K160216 |
04/22/2016 |
Revolution Spinal Fixation System |
INTELLIGENT IMPLANT SYSTEMS, LLC |
MICHAEL NUTT |
| K153766 |
04/08/2016 |
Clalen 54 (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, Clalen 58 (hioxifilcon A) Soft (hydrophilic) Contact Lens for Daily Wear |
Interojo Inc. |
Si-Chul Rho |
| K160464 |
04/04/2016 |
Opticage(R) Expandable Interbody Fusion Device |
INTERVENTIONAL SPINE, INC. |
JANE METCALF |
| K152892 |
04/29/2016 |
da Vinci Xi Surgical System |
INTUITIVE SURGICAL |
Crystal Ong |
| K152493 |
04/25/2016 |
POGO Automatic Blood Glucose Monitoring System |
INTUITY MEDICAL, INC |
Robb Hesley |
| K143605 |
04/14/2016 |
Nutraseb Facial Cream |
ISDIN Corp |
STEVE SMITH |
| K152727 |
04/26/2016 |
ISEN-Goggles |
ISEN TECH & TRADING COMPANY, LTD. |
MARTIN LIU |
| K153753 |
04/12/2016 |
TelioCAD Multi |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K152538 |
04/13/2016 |
JRP Wound Spreader |
J.R. PARKER, LLC |
J RICHARD PARKER |
| K153624 |
04/15/2016 |
Neodent Implant System |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
Jacson Cambruzzi |
| K160125 |
04/22/2016 |
Cascadia Interbody System |
K2M |
Nancy Giezen |
| K153526 |
04/27/2016 |
Pyrenees Cervical Plate System |
K2M |
Nancy Giezen |
| K160013 |
04/29/2016 |
Crosperio OTW |
KANEKA CORPORATION |
TOSHIHIKO MOTOMINE |
| K160004 |
04/29/2016 |
Crosstella OTW |
KANEKA CORPORATION |
TOSHIHIKO MOTOMINE |
| K160142 |
04/21/2016 |
MINERAL OIL |
KITAZATO BIOPHARMA CO., LTD. |
Futoshi INOUE |
| K151983 |
04/06/2016 |
KLS Martin LSS Plating System |
KLS MARTIN L.P. |
JENNIFER DAMATO |
| K153482 |
04/06/2016 |
KLS Martin Thoracic Plating System |
KLS-MARTIN L.P. |
Jennifer Damato |
| DEN150030 |
04/25/2016 |
KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay |
KRONUS, INC. |
BRIAN DEIS |
| K152581 |
04/11/2016 |
LifeGlobal Micro Tips |
LifeGlobal Group, LLC |
Michael D. Cecchi |
| K153722 |
04/06/2016 |
SMR 3-Pegs Glenoids |
Limacorporate S.p.A. |
Emmanuele Buttazzoni |
| K153698 |
04/19/2016 |
LumenR Tissue Retractor System |
LumenR, LLC |
GREGORY PISKUN |
| K160517 |
04/12/2016 |
ARIES System |
LUMINEX CORPORATION |
Wendy Ricker |
| K160318 |
04/01/2016 |
PlasmaFlow |
MANAMED, INC |
Trevor Theriot |
| K153194 |
04/19/2016 |
VASOVIEW HemoPro Endoscopic Vessel Harvesting System |
MAQUET CARDIOVASCULAR, LLC |
MARK DINGER |
| K153602 |
04/26/2016 |
Materialise Glenoid Positioning System |
MATERIALISE NV |
OLIVER CLEMENS |
| K160172 |
04/21/2016 |
Laparoscope Lens Shield Device |
Medeon Biodesign, Inc |
Greta Chang |
| K153168 |
04/29/2016 |
Bi-Blade Vitrectomy Cutter |
MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES |
Brenda Balletto |
| K153413 |
04/22/2016 |
PASS LP Spinal System |
MEDICREA INTERNATIONAL S.A. |
DAVID RYAN |
| K160756 |
04/26/2016 |
PASS OCT Spinal System |
MEDICREA INTERNATIONAL S.A. |
David Ryan |
| K152299 |
04/29/2016 |
TBS iNsight |
MEDIMAPS GROUP SA |
CHRISTOPHE LELONG |
| K150598 |
04/28/2016 |
Blockade Surgical Gown |
Medline Industries, Inc. |
Matt Clausen |
| K153555 |
04/07/2016 |
EM ENT Navigated Suctions |
MEDTRONIC NAVIGATION, INC. |
Carey Brenner |
| K152700 |
04/07/2016 |
StrataMR Valves and Shunts |
MEDTRONIC NEUROSURGERY |
Micah Schloss |
| K153038 |
04/13/2016 |
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit |
MEDTRONIC, INC. |
NISARG SHAH |
| K160689 |
04/22/2016 |
Reveal LINQ |
MEDTRONIC, INC. |
Eric Kalmes |
| K153501 |
04/15/2016 |
Bullfrog Micro-Infusion Device |
MERCATOR MEDSYSTEMS, INC. |
KIRK P. SEWARD |
| K160548 |
04/29/2016 |
MC-Subtalar(TM) II |
MERETE MEDICAL GMBH |
PAUL MUNCH |
| K152864 |
04/07/2016 |
Merge Hemo |
MERGE HEALTHCARE INCORPORATED |
MIKE DIEDRICK |
| K151967 |
04/04/2016 |
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter |
Merit Medical Systems, Inc. |
Susan Christensen |
| K152934 |
04/25/2016 |
MMS PTA Balloon Catheter |
MicroMedical Solutions, Inc. |
Gregory Mathison |
| K151913 |
04/25/2016 |
MIM-Thin Client (mobile) |
MIM Software Inc. |
Lynn Hanigan |
| K160126 |
04/19/2016 |
AIRO Computed Tomography (CT) X-ray System |
Mobius Imaging |
Norma J LeMay |
| K153014 |
04/29/2016 |
Mobius3D |
MOBIUS MEDICAL SYSTEMS, LP |
STAN ESHELMAN |
| K152059 |
04/21/2016 |
Disposable General Electrode |
MODERN MEDICAL EQUIPMENT MANUFACTURING LIMITED |
THOMAS CHAN TSZ FUNG |
| K160500 |
04/20/2016 |
Elite SPK, Compasso, Elite SPK Kit |
NCS Lab Srl |
Matteo Mantovani |
| K153084 |
04/08/2016 |
Nephros S100 |
NEPHROS INC. |
JAMES SUMMERTON |
| K153453 |
04/26/2016 |
Inertia Pedicle Screw and Deformity Correxxion System |
NEXXT SPINE LLC |
ANDY ELSBURY |
| K152305 |
04/08/2016 |
Nihon Kohden Afib Detection Program QP-039P |
NIHON KOHDEN CORPORATION |
TOM BENTO |
| K153251 |
04/14/2016 |
Tenso TS-101S and TS-101D Disposable Blood Pressure Cuff |
NINGBO FREE TRADE ZONE TENSO MEDICAL INSTRUMENTS CO., LTD. |
CHARLES SHEN |
| K152836 |
04/11/2016 |
TREFOIL System |
NOBEL BIOCARE AB |
CHARLEMAGNE CHUA |
| K153043 |
04/11/2016 |
Noris Medical MBI Dental Implant System |
NORIS MEDICAL LTD. |
Simha Sibony |
| K151909 |
04/08/2016 |
Noris Medical Zygomatic Dental Implant System |
NORIS MEDICAL LTD. |
SIMHA SIBONY |
| K160608 |
04/13/2016 |
NormaTec Pulse and NormaTec Pulse Pro |
NORMATEC INDUSTRIES, LP |
Peter Novello |
| K153419 |
04/13/2016 |
NuVasive CoRoent Thoracolumbar System |
NUVASIVE, INCORPORATED |
Michelle Cheung |
| K160051 |
04/20/2016 |
NuVasive« Interfixated Interbody System |
NuVasive, Incorporated |
Michelle Cheung |
| K153648 |
04/19/2016 |
Microcyn Plus Skin and Wound Hydrogel |
OCULUS INNOVATIVE SCIENCES |
Brian W. Martin |
| K160249 |
04/21/2016 |
ULTRA Telescopes |
Olympus Winter & Ibe GmbH |
Katharina Campbell |
| K153009 |
04/05/2016 |
ULTRA Telescopes |
OLYMPUS, WINTER & IBE GMBH |
Katharina Schnackenburg |
| K160407 |
04/08/2016 |
spineEOS |
ONEFIT MEDICAL |
JULIEN SIMON |
| K150372 |
04/15/2016 |
VERASENSE Knee System |
OrthoSensor, Inc. |
Kimberlee Washburn |
| K160522 |
04/26/2016 |
White Pearl Preferred Angle Anterior Cervical Plate |
OSSEUS FUSION SYSTEMS, LLC |
Robert Pace |
| K151608 |
04/13/2016 |
4plus6Line Abutment System |
OT MEDICAL GMBH |
Martina Behlau |
| K152223 |
04/29/2016 |
Rectangular Multiplace Hyperbaric Chamber System Product Family with Touchscreen Control System |
OXYHEAL MEDICAL SYSTEMS, INC. |
Edward J Chomas |
| K152364 |
04/14/2016 |
uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS |
PC Marketing, Inc. |
Michael Rolls |
| K160832 |
04/20/2016 |
Penumbra Smart Coil |
PENUMBRA, INC. |
Charles DeNault |
| K160304 |
04/29/2016 |
OsteoBullet Compression Screw |
Phalanx Innovations |
Daniel Lanois |
| K160194 |
04/26/2016 |
StarFuse Interphalangeal Pin |
Phalanx Innovations |
Daniel Lanois |
| K153444 |
04/08/2016 |
Philips Multislice CT System with Low Dose CT Lung Cancer |
PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC. |
Michael Chilbert |
| K160807 |
04/06/2016 |
EPIQ 5 Diagnostic Ultrasound System, EPIQ 7Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System |
PHILIPS ULTRASOUND, INC. |
PENG CUI |
| K153655 |
04/15/2016 |
Accuryn Monitoring System |
POTRERO MEDICAL, INC. |
DEVYANI NANDURI |
| K143477 |
04/14/2016 |
Nitrile Patient Examination gloves, Powderfree, Blue color |
PRIMUS GLOVES PVT LIMITED |
JOSE PAUL M |
| K152619 |
04/29/2016 |
Neoscope 3D - 3D Digital Video Endoscopic System (Rigid/Flexible) |
PROSURG, INC. |
ASHVIN DESAI |
| K153249 |
04/01/2016 |
Pulpdent Solo Flowable Composite with MCP |
Pulpdent Corporation |
Kenneth J Berk |
| K160368 |
04/05/2016 |
EVO platform |
Quanta System SpA |
FRANCESCO DELL'ANTONIO |
| K152117 |
04/21/2016 |
Dropper hsCRP High Sensitivity CRP Control |
Quantimetrix Corporation |
Kaylna Snylyk |
| K160788 |
04/15/2016 |
RIOScan (RPS500) |
RAY CO., Ltd |
Changhwan Lee |
| K160579 |
04/08/2016 |
Xmaru View V1 and Xmaru PACS, Medical Image Processing Software |
RAYENCE CO., LTD |
Kevin Kim |
| K160093 |
04/08/2016 |
RayStation |
RaySearch Laboratories AB (publ) |
David Hedfors |
| K153163 |
04/07/2016 |
ReGrasp |
Rehabtronics Inc. |
Mike Pearson |
| K153061 |
04/13/2016 |
Juno VPAP ST-A |
RESMED LTD |
Jean-Nicolas BOUDAUD |
| K151120 |
04/15/2016 |
Simple T Pediatric Nasal Mask |
RESPIRONICS, INC. |
SHAYLEE MASILUNAS |
| K152227 |
04/27/2016 |
Elecsys Cortisol II, Cortisol II CalSet |
ROCHE DIAGNOSTICS |
KELLI TURNER |
| K153301 |
04/08/2016 |
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II |
ROCHE DIAGNOSTICS |
EDIE EADS |
| K151874 |
04/15/2016 |
BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal |
Salter Labs |
Mara Caler |
| K160320 |
04/01/2016 |
Premier |
Shandong Weigao Orthopaedic Device Co., Ltd |
Han Wang |
| K142263 |
04/15/2016 |
Applanation Tonometer |
SHANGHAI MEDIWORKS PRECISION INSTRUMENTS CO. LTD. |
Weida Zhan |
| K160019 |
04/22/2016 |
U80 Series Upper Arm Electronic Blood Pressure Monitor |
SHENZHEN URION TECHNOLOGY CO.,LTD |
AUTUMN LIU |
| K160202 |
04/27/2016 |
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Laura J. Duggan |
| K153343 |
04/15/2016 |
MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit |
SIEMENS MEDICAL SOLUTIONS, INC. |
JOHN URTZ |
| K151704 |
04/13/2016 |
Diplomat« Spinal System |
SIGNUS Medizintechnik GmbH |
Jochim Schneider |
| K153098 |
04/08/2016 |
KLOCKNER VEGA DENTAL IMPLANT SYSTEM |
SOADCO, S.L. |
MARIA MITJANETA |
| K160283 |
04/04/2016 |
S45 Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K160258 |
04/01/2016 |
X5 Digital Color Doppler Ultrasound System |
SONOSCAPE MEDICAL CORP. |
Toki Wu |
| K152881 |
04/01/2016 |
SENTINEL CARDIOLOGY INFORMATION MANAGEMENT SYSTEM |
SPACELABS HEALTHCARE LTD. |
AL VAN HOUDT |
| K153222 |
04/15/2016 |
Leva Spacer System |
SPINE WAVE, INC. |
Gail Yaeker-Daunis |
| K160124 |
04/04/2016 |
LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System |
SpineVision S.A. |
Helene Plas |
| K160716 |
04/14/2016 |
The Nanostim Introducer Kit |
St Jude Medical, Inc |
Brittany Cunningham |
| K151922 |
04/15/2016 |
StimSox(TM) System |
StimMed, LLC |
Robert E Kaplan |
| K160693 |
04/13/2016 |
Neptune E-SEP Smoke Evacuation Pencil |
STRYKER CORPORATION |
MAIREAD TWOMEY |
| K153407 |
04/25/2016 |
Stryker Neptune 3 Waste Management System |
STRYKER CORPORATION |
KIM WIERSEMA |
| K153377 |
04/11/2016 |
Hoffmann LRF (Limb Reconstruction Frame) System |
Stryker GmbH |
Paul Nelson |
| K142754 |
04/07/2016 |
Surearly Pregnancy Test Strip, Surearly Digital Pregnancy Test |
Sugentech, Inc. |
Mijin Sohn |
| K153258 |
04/05/2016 |
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars |
Surgical Instrument Service and Savings (dba Medline ReNewal |
Brandi J Panteleon |
| K151855 |
04/15/2016 |
SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber |
SURGICAL LASER INCORPORATED |
GORDON WILLOX |
| K152959 |
04/14/2016 |
Sealapex tubes, Sealapex bulk package, Sealapex Xpress dual-barrel syringes |
Sybron Dental Specialties |
Courtney Clark |
| K152111 |
04/14/2016 |
Symmetry Surgical Quad-Lock Container System |
SYMMETRY SURGICAL INC. |
LORA TJOMSTOL |
| K151588 |
04/25/2016 |
maxFit II Dental Implant System |
Taiwan Implant Technology Company, Ltd. |
Ching-Chieh Huang |
| K152412 |
04/29/2016 |
T-32;T-40;T-44;T-52;T-72;TT-50 |
Tanses Technologies inc. |
Kirk Kiremitci |
| K152973 |
04/29/2016 |
Dyna-Vision Telemonitoring System |
Techmedic Development International B.V. |
Rutger Brest van Kempen |
| K153063 |
04/08/2016 |
PERCUVANCE PERCUTANEOUS SURGICAL SYSTEM |
Teleflex Medical, Inc. |
HOLLY HALLOCK |
| K160206 |
04/21/2016 |
VirtuoSaph Plus Endoscopic Vessel Harvesting System |
Terumo Cardiovascular Systems Corporation |
Tierra A Brown |
| K160792 |
04/15/2016 |
Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound |
THE PROMETHEUS GROUP |
Joshua Bird |
| K160376 |
04/12/2016 |
EndoSize |
Therenva SAS |
Cemil Goksu |
| K152947 |
04/05/2016 |
Disposable Temporary Pacing Cable |
TIGER MEDICAL PRODUCTS |
Veronica Lee |
| K153263 |
04/01/2016 |
Aquilion Lightning, TSX-035A/4 and /5, V7.0 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K152194 |
04/07/2016 |
transGlide Expandable Introducer |
TRANSAORTIC MEDICAL, INC. |
RICHARD GINN |
| K160211 |
04/27/2016 |
Wet Original Personal Lubricant |
TRIGG LABORATORIES D/B/A WET INTERNATIONAL |
ERICA LORING |
| K160177 |
04/22/2016 |
Gridlock Ankle Plating System |
Trilliant Surgical, LTD |
Jon Olson |
| K152184 |
04/08/2016 |
MagView BIOMAGNETOMETER SYSTEM |
TRISTAN TECHNOLOGIES, INC |
KEVIN PRATT |
| K143548 |
04/01/2016 |
TRUE METRIX GO Self Monitoring Blood Glucose System |
Trividia Health, Inc. |
Beth Foster |
| K152430 |
04/12/2016 |
All Poly Tibial Component |
UNITED ORTHOPEDIC CORPORATION |
KAREN HO |
| K152439 |
04/07/2016 |
U2 Bipolar Implant and 22mm Femoral Head |
UNITED ORTHOPEDIC CORPORATION |
Karen Ho |
| K150476 |
04/15/2016 |
Spectra S1Plus and Spectra S2 Plus |
UZINMEDICARE CO. |
Ho Jun Kang |
| K160021 |
04/13/2016 |
Varian Sterilization Boxes |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J. Coronado |
| K153562 |
04/01/2016 |
Powder Free Blue Nitrile Examination Glove |
Viet Glove Corporation |
Pham Ngoc Thanh |
| K160355 |
04/07/2016 |
CX20N(CX20PUX) |
WIDE Corporation |
YeoJin Yun |
| K160348 |
04/14/2016 |
CX30N (CX30PQX) |
WIDE CORPORATION |
YEOJIN YUN |
| K160351 |
04/07/2016 |
CX50N, CX50YQS |
WIDE Corporation |
YeoJin Yun |
| K160346 |
04/14/2016 |
MX30N(MX30TQS) |
WIDE Corporation |
YeoJin Yun |
| K160353 |
04/22/2016 |
MX50N(MX50YQS) |
WIDE Corporation |
YeoJin Yun |
| K160814 |
04/22/2016 |
Sydney IVF Sperm Cryopreservation Buffer |
WILLIAM A. COOK AUSTRALIA PTY LTD |
GORDANA POZVEK |
| K152056 |
04/11/2016 |
Winco Model S550 Stretchair |
WINCO MANUFACTURING LLC |
JAMES ANKOVIAK |
| K150921 |
04/12/2016 |
Orbit Infusion Set |
YPSOMED AG |
STEPHAN AFFOLTER |
| K153404 |
04/21/2016 |
Zavation Spinal System |
ZAVATION, LLC |
Lawrence Walker |
